Trial Outcomes & Findings for Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population (NCT NCT03593655)

Last Updated: 2023-06-22

Results Overview

During participants' first year on study (i.e., during first and second product use periods) participants were randomized to use either the dapivirine vaginal ring for 6 months followed by FTC/TDF for 6 months or vice versa. All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. AEs that were graded as at least Grade 2 (i.e., "moderate" or higher) were classified into the two periods based on reported date of AE onset, with AEs occurring between the participant's randomization date and the date 30 days after their Week 24 visit classified into Period 1, and AEs occurring between their Week 24 visit and the date 30 days after their Week 48 visit classified into Period 2. AEs occurring within 30 days of the Week 24 visit were counted in both periods. This is the number of participant-periods with at least one grade 2 or higher AE by product (combining the two product use periods).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

247 participants

Primary outcome timeframe

Study periods 1 and 2

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence A: Dapivirine Vaginal Ring + FTC/TDF Participants will receive one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Dapivirine vaginal ring: Vaginal ring containing 25 mg of dapivirine FTC/TDF: Tablet containing 200 mg FTC/300 mg TDF	Sequence B: FTC/TDF + Dapivirine Vaginal Ring Participants will receive one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Dapivirine vaginal ring: Vaginal ring containing 25 mg of dapivirine FTC/TDF: Tablet containing 200 mg FTC/300 mg TDF
First Product Use Period STARTED	124	123
First Product Use Period COMPLETED	122	119
First Product Use Period NOT COMPLETED	2	4
Second Product Use Period STARTED	122	119
Second Product Use Period COMPLETED	120	118
Second Product Use Period NOT COMPLETED	2	1
Third Product Use Period STARTED	120	118
Third Product Use Period Always Chose Dapivirine Vaginal Ring	66	71
Third Product Use Period Always Chose FTC/TDF	35	27
Third Product Use Period At Least One Switch	17	13
Third Product Use Period Never Chose Either Product	2	7
Third Product Use Period COMPLETED	119	114
Third Product Use Period NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence A: Dapivirine Vaginal Ring + FTC/TDF Participants will receive one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Dapivirine vaginal ring: Vaginal ring containing 25 mg of dapivirine FTC/TDF: Tablet containing 200 mg FTC/300 mg TDF	Sequence B: FTC/TDF + Dapivirine Vaginal Ring Participants will receive one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Dapivirine vaginal ring: Vaginal ring containing 25 mg of dapivirine FTC/TDF: Tablet containing 200 mg FTC/300 mg TDF
First Product Use Period Withdrawal by Subject	1	1
First Product Use Period Lost to Follow-up	1	3
Second Product Use Period Withdrawal by Subject	1	1
Second Product Use Period Lost to Follow-up	1	0
Third Product Use Period Lost to Follow-up	1	2
Third Product Use Period Physician Decision	0	1
Third Product Use Period Withdrawal by Subject	0	1

Baseline Characteristics

Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence A: Dapivirine Vaginal Ring + FTC/TDF n=124 Participants Participants will receive one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Dapivirine vaginal ring: Vaginal ring containing 25 mg of dapivirine FTC/TDF: Tablet containing 200 mg FTC/300 mg TDF	Sequence B: FTC/TDF + Dapivirine Vaginal Ring n=123 Participants Participants will receive one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Dapivirine vaginal ring: Vaginal ring containing 25 mg of dapivirine FTC/TDF: Tablet containing 200 mg FTC/300 mg TDF	Total n=247 Participants Total of all reporting groups
Age, Continuous	18.3 years STANDARD_DEVIATION 1.4 • n=5 Participants	18.2 years STANDARD_DEVIATION 1.4 • n=7 Participants	18.3 years STANDARD_DEVIATION 1.4 • n=5 Participants
Age, Customized 16-17 years	41 Participants n=5 Participants	44 Participants n=7 Participants	85 Participants n=5 Participants
Age, Customized 18-19 years	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Age, Customized 20-21 years	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	123 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants n=5 Participants	123 Participants n=7 Participants	247 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	120 Participants n=5 Participants	119 Participants n=7 Participants	239 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Uganda	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment Zimbabwe	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment South Africa	64 participants n=5 Participants	63 participants n=7 Participants	127 participants n=5 Participants

PRIMARY outcome

Timeframe: Study periods 1 and 2

Population: All participants who attended at least one visit during the product use period where they were randomized to receive the product (e.g., a participant randomized to Sequence A would be in the analysis population for dapivirine vaginal ring due to being randomized, and would be in the analysis population for FTC/TDF if they attended any study visits during the second product use period).

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=241 Participants The period during the first two product use periods where the participant was randomized to use the dapivirine ring. This is the first product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive the dapivirine vaginal ring during their first product use period) or the second product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive the dapivirine vaginal ring during their second product use period).	FTC/TDF n=245 Participants The period during the first two product use periods where the participant was randomized to use FTC/TDF. This is the first product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive FTC/TDF during their first product use period) or the second product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive FTC/TDF during their second product use period).
Number of Participants With Grade 2 or Higher Adverse Events (AEs) Study Period 1 (Weeks 1-24) · No grade 2+ AE	36 Participants	36 Participants
Number of Participants With Grade 2 or Higher Adverse Events (AEs) Study Period 1 (Weeks 1-24) · At least one grade 2+ AE	88 Participants	87 Participants
Number of Participants With Grade 2 or Higher Adverse Events (AEs) Study Period 2 (Weeks 25-48) · No grade 2+ AE	22 Participants	28 Participants
Number of Participants With Grade 2 or Higher Adverse Events (AEs) Study Period 2 (Weeks 25-48) · At least one grade 2+ AE	95 Participants	94 Participants

PRIMARY outcome

Timeframe: Study periods 1 and 2

Population: Number of participant-visits during product use periods randomized to each product for which there is adherence data available.

During the study period where participants were randomized to use FTC/TDF they were assessed for FTC/TDF adherence by dried blood spot (DBS) at monthly visits. Results that were below the lower limit of detection (\< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (\>= 16.6 fmol/punch) classified as at least some FTC/TDF use. During the study period where participants were randomized to use the dapivirine vaginal ring (VR) they were assessed for ring adherence by residual drug levels in returned VRs. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use.

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=1407 Visits The period during the first two product use periods where the participant was randomized to use the dapivirine ring. This is the first product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive the dapivirine vaginal ring during their first product use period) or the second product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive the dapivirine vaginal ring during their second product use period).	FTC/TDF n=1316 Visits The period during the first two product use periods where the participant was randomized to use FTC/TDF. This is the first product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive FTC/TDF during their first product use period) or the second product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive FTC/TDF during their second product use period).
Number of Participant-Visits With No Product Use Study Period 1 · No use	19 Visits	11 Visits
Number of Participant-Visits With No Product Use Study Period 1 · At least some use	705 Visits	660 Visits
Number of Participant-Visits With No Product Use Study Period 2 · No use	41 Visits	10 Visits
Number of Participant-Visits With No Product Use Study Period 2 · At least some use	642 Visits	635 Visits

SECONDARY outcome

Timeframe: Study periods 1 and 2

Population: Number of participant-visits during product use periods randomized to each product for which there are responses to the question about acceptability.

During the study period where participants were randomized to use FTC/TDF they were asked to rate how much they liked using the tablets for HIV prevention (3 and 6 months after initiating the product). During the study period where participants were randomized to use the dapivirine vaginal ring they were asked to rate how much they liked using the ring for HIV prevention (3 and 6 months after initiating the product).

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=437 Visits The period during the first two product use periods where the participant was randomized to use the dapivirine ring. This is the first product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive the dapivirine vaginal ring during their first product use period) or the second product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive the dapivirine vaginal ring during their second product use period).	FTC/TDF n=438 Visits The period during the first two product use periods where the participant was randomized to use FTC/TDF. This is the first product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive FTC/TDF during their first product use period) or the second product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive FTC/TDF during their second product use period).
Number of Participant-Visits Reporting Acceptability of Study Product Week 36 · Like, or like very much	91 Visits	93 Visits
Number of Participant-Visits Reporting Acceptability of Study Product Week 12 · Like, or like very much	105 Visits	72 Visits
Number of Participant-Visits Reporting Acceptability of Study Product Week 12 · Neither like nor dislike, dislike, or dislike very much	5 Visits	35 Visits
Number of Participant-Visits Reporting Acceptability of Study Product Week 24 · Like, or like very much	105 Visits	73 Visits
Number of Participant-Visits Reporting Acceptability of Study Product Week 24 · Neither like nor dislike, dislike, or dislike very much	6 Visits	32 Visits
Number of Participant-Visits Reporting Acceptability of Study Product Week 36 · Neither like nor dislike, dislike, or dislike very much	14 Visits	18 Visits
Number of Participant-Visits Reporting Acceptability of Study Product Week 48 · Like, or like very much	90 Visits	68 Visits
Number of Participant-Visits Reporting Acceptability of Study Product Week 48 · Neither like nor dislike, dislike, or dislike very much	21 Visits	47 Visits

SECONDARY outcome

Timeframe: Study period 3 (Weeks 49-72)

Population: Number of participant-visits during product choice period for which there is adherence data available.

During the study period where participants chose which product they used (i.e., Weeks 49-72) they were assessed for FTC/TDF adherence by dried blood spot (DBS) and/or dapivirine vaginal ring adherence by residual drug levels in returned VRs at monthly visits, depending on which product they chose. Results that were below the lower limit of detection (\< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (\>= 16.6 fmol/punch) classified as at least some FTC/TDF use. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use.

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=857 Visits The period during the first two product use periods where the participant was randomized to use the dapivirine ring. This is the first product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive the dapivirine vaginal ring during their first product use period) or the second product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive the dapivirine vaginal ring during their second product use period).	FTC/TDF n=400 Visits The period during the first two product use periods where the participant was randomized to use FTC/TDF. This is the first product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive FTC/TDF during their first product use period) or the second product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive FTC/TDF during their second product use period).
Number of Participant-Visits With No Product Use No use	57 Visits	19 Visits
Number of Participant-Visits With No Product Use At least some use	800 Visits	381 Visits

SECONDARY outcome

Timeframe: Study period 3 (Weeks 49-72)

Population: All participants who attended at least one visit during study period 3

During the third study product use period (i.e., Weeks 49-72) participants chose whether to use the dapivirine VR, FTC/TDF oral tablets, or neither product, and could change their decision throughout the 6 month period. Participants were categorized into one of four categories based on their selection pattern: always chose dapivirine VR, always chose FTC/TDF oral tablets, switched at least once (including switching to or from no product), and never chose either product.

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=120 Participants The period during the first two product use periods where the participant was randomized to use the dapivirine ring. This is the first product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive the dapivirine vaginal ring during their first product use period) or the second product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive the dapivirine vaginal ring during their second product use period).	FTC/TDF n=118 Participants The period during the first two product use periods where the participant was randomized to use FTC/TDF. This is the first product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive FTC/TDF during their first product use period) or the second product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive FTC/TDF during their second product use period).
Number of Participants Selecting Each Study Product Always chose ring	66 Participants	71 Participants
Number of Participants Selecting Each Study Product Always chose tablets	35 Participants	27 Participants
Number of Participants Selecting Each Study Product At least one switch	17 Participants	13 Participants
Number of Participants Selecting Each Study Product Never chose ring or tablets	2 Participants	7 Participants

SECONDARY outcome

Timeframe: All three study periods (enrollment, month 12, and month 18 study visits)

Population: The analysis population is all participants who completed the questionnaire at the visit.

Participants were asked "would you prefer to use the ring or the tablets for HIV prevention?" at their enrollment, Month 12, and product use end visit (Month 18) visits.

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=124 Participants The period during the first two product use periods where the participant was randomized to use the dapivirine ring. This is the first product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive the dapivirine vaginal ring during their first product use period) or the second product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive the dapivirine vaginal ring during their second product use period).	FTC/TDF n=123 Participants The period during the first two product use periods where the participant was randomized to use FTC/TDF. This is the first product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive FTC/TDF during their first product use period) or the second product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive FTC/TDF during their second product use period).
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Enrollment · Preferred ring	51 Participants	43 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Enrollment · Preferred tablets	43 Participants	57 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Enrollment · Either product equally	29 Participants	18 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Enrollment · Neither product	0 Participants	4 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Enrollment · Skipped question	1 Participants	1 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 12 · Preferred ring	74 Participants	76 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 12 · Preferred tablets	37 Participants	30 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 12 · Either product equally	5 Participants	2 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 12 · Neither product	0 Participants	2 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 12 · Skipped question	0 Participants	1 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 18 · Preferred ring	67 Participants	66 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 18 · Preferred tablets	35 Participants	33 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 18 · Either product equally	13 Participants	5 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 18 · Neither product	0 Participants	4 Participants
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets Month 18 · Skipped question	0 Participants	0 Participants

Adverse Events

Dapivirine Vaginal Ring (Periods 1 and 2)

Serious events: 0 serious events

Other events: 205 other events

Deaths: 0 deaths

FTC/TDF (Periods 1 and 2)

Serious events: 3 serious events

Other events: 219 other events

Deaths: 0 deaths

Choice Period (Period 3)

Serious events: 3 serious events

Other events: 203 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dapivirine Vaginal Ring (Periods 1 and 2) n=241 participants at risk The period during the first two product use periods where the participant was randomized to use the dapivirine ring. This is the first product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive the dapivirine vaginal ring during their first product use period) or the second product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive the dapivirine vaginal ring during their second product use period).	FTC/TDF (Periods 1 and 2) n=245 participants at risk The period during the first two product use periods where the participant was randomized to use FTC/TDF. This is the first product use period for participants randomized to Sequence B (i.e., participants who were randomized to receive FTC/TDF during their first product use period) or the second product use period for participants randomized to Sequence A (i.e., participants who were randomized to receive FTC/TDF during their second product use period).	Choice Period (Period 3) n=238 participants at risk The third study period was intended to assess product choice and not inform the safety profile of the products. As such, the third study period was designed to allow participants to choose the dapivirine ring, oral FTC/TDF, or neither product. Because participants could also choose to switch between these three options throughout the study period without any washout period between switches, it is not possible to ascribe AEs to a specific product. Therefore, adverse events occurring during this period are combined.
Reproductive system and breast disorders Any Event in SOC	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.41% 1/245 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/238 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.41% 1/245 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/238 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Infections and infestations Any Event in SOC	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.41% 1/245 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.84% 2/238 • Number of events 2 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Infections and infestations Appendicitis	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/245 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.42% 1/238 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Infections and infestations Pelvic inflammatory disease	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.41% 1/245 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/238 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Infections and infestations Urinary tract infection	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/245 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.42% 1/238 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Injury, poisoning and procedural complications Any Event in SOC	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/245 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.42% 1/238 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/245 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.42% 1/238 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Nervous system disorders Any Event in SOC	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.41% 1/245 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/238 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
Nervous system disorders Headache	0.00% 0/241 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.41% 1/245 • Number of events 1 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.	0.00% 0/238 • Adverse event data were collected over the duration of participants' time on study (18 months) The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.

Other adverse events

Additional Information

Gonasagrie Nair

Stellenbosch University, Centre for Medical Ethics and Law

Phone: 27-21-938-7050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place